Clinical Development

Clinical Trials

NOSTRA III confirmatory trial

The NOSTRA (NOSynthase Inhibition in TRAumatic brain injury) III trial examines VAS203 in patients who have sustained an acute brain injury. NOSTRA III is a European placebo-controlled, randomised, double-blind, multi-centre study entitled “Efficacy of VAS203 in patients with moderate and severe traumatic brain injury (NOSTRA Phase III trial)” (NCT02794168). NOSTRA III is conducted in up to 35 European centres in Austria, France, Germany, Spain and the UK. The trial plans to recruit 220 evaluable patients, randomised 1:1 VAS203 or placebo, given in addition to best standard of care. The first patient was enrolled on 24th August 2016.The trial seeks to confirm the results of the NOSTRA II trial.

NOSTRA II Proof-of-Concept trial

NOSTRA II was an exploratory placebo-controlled, randomised, multi-centre study comparing VAS203 to placebo, on top of best standard of care. The trial was conducted in six centres in Austria, France, Spain, Switzerland and the UK. VAS203 treated patients had a significantly better clinical outcome than patients given placebo, as assessed by the therapy intensity level (at day 6 after brain injury) and the extended Glasgow Outcome Score (at month 6 and 12 after brain injury). The trial results strongly indicate that VAS203 may have a neuroprotective role in patients with TBI.

NOSTRA II also assessed cerebral pharmacokinetics (PK) and pharmacodynamic markers (PD) by analysing cerebral microdialysate samples. VAS203 and its metabolites were detected in these samples. Further, PD data in cerebral microdialysate samples were supportive of the assumed mechanism of action, namely to inhibit iNOS.

Phase I studies

2007, Jul

Completion of first-in-human single ascending dose study in healthy volunteers

2009, Sep

Completion of repeated-dose dose study in healthy volunteers

2017, Feb

Completion of clinical study on effects of VAS203 in renal perfusion in healthy volunteers

Relevant Infomation

In 2006 vasopharm obtained orphan medicinal product designation by the European Medicines Agency

The World Health Organization (WHO) allocated the International Nonproprietary Name (INN) "Ronopterin" to VAS203 in November 2014